On Thursday, Avenue Therapeutics (NASDAQ: ATXI) stock surged by almost 96% after the specialty pharmaceutical company secured final approval from the U.S. Food and Drug Administration (FDA) for a Phase 3 Safety Study on IV Tramadol.
Avenue Therapeutics has announced a final agreement with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 safety study protocol for intravenous (IV) tramadol.
The Phase 3 study aims to evaluate the theoretical risk of opioid-induced respiratory depression associated with opioid stacking on IV tramadol compared to IV morphine. This study is a critical step in the development of IV tramadol for the treatment of acute post-operative pain in a medically supervised setting.
Alexandra MacLean, M.D., Chief Executive Officer of Avenue, said,
“We have worked collaboratively with the FDA over the last year to design a study that will address a theoretical safety risk. We are pleased with the agreed-upon plan for the clinical trial and believe that this trial will support a safe profile for IV tramadol administration for acute pain in the post-operative period.”
The study will include around 300 post-bunionectomy patients, randomizing them to receive either IV tramadol or IV morphine for pain relief during a 48-hour post-operative period. Of note, IV tramadol has previously demonstrated safety and efficacy in this surgical model during two Phase 3 efficacy trials. Patients will also have access to IV hydromorphone, a Schedule II opioid, for breakthrough pain relief, with the primary endpoint being a composite of elements indicative of respiratory depression.
Avenue Therapeutics (NASDAQ: ATXI) plans to complete the study in 12 months and submit the results to the FDA. Positive outcomes could result in FDA approval.
Dr. MacLean continued,
“Subject to obtaining the necessary financing, which could be provided through a strategic partnership, Avenue plans to initiate the Phase 3 safety study as soon as possible, and could potentially have study results in-hand as early as the end of this year. We expect that a positive study outcome could result in the FDA approval of IV tramadol, potentially improving the current treatment paradigm available for U.S. patients in managing post-operative pain and providing significant near-term value for Avenue shareholders.”
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